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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Candulor TCR

    DI: E1997573491 · Model: 757349 · Candulor AG
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Candulor TCR
    Primary DI
    E1997573491
    Version / Model
    757349
    Catalog Number
    757349
    Company Name
    Candulor AG
    Labeler DUNS
    480467422
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-10-27
    Public Version
    1
    Public Version Date
    2022-11-04
    Public Version Status
    New
    Public Device Record Key
    1305d0d2-c541-45db-8230-ae25daad8f82

    Device Description

    Physioset TCR Set of 6 UX107 D4

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    ELM Denture, plastic, teeth

    GMDN Terms

    Code Name
    38643 Resin artificial teeth

    Identifiers

    Type ID
    Primary E1997573491